24 January 2019 - - The US Patent and Trademark Office has issued two new US patents for US-based CEL-SCI Corp.'s (NYSE American: CVM) LEAPS platform technology, the company said.

These include Patent #10,179,174 B2 titled "Method for inducing an immune response and formulations thereof" is focused on influenza; and Patent #10,179,164 B2 titled "Method for inducing an immune response for treatment of cancer and autoimmune diseases or conditions".

CEL-SCI's LEAPS inventions relate to methods for diagnosing, preventing, and treating disease by generating or modulating the immune response through the use of specific peptides.

LEAPS is a patented, T-cell modulation, peptide epitope delivery technology that enables CEL-SCI to design and synthesize proprietary peptide immunogens. LEAPS compounds consist of a small T-cell binding peptide ligand linked with a disease-associated peptide antigen.

The LEAPS platform technology is currently being developed as a therapeutic vaccine for rheumatoid arthritis under a USD1.5 m grant from the US National Institutes of Health.

Upon completion of preclinical and Investigational New Drug enabling studies for the LEAPS-based rheumatoid arthritis vaccine candidate CEL-4000, CEL-SCI intends to file an IND application with the US Food and Drug Administration.

This platform technology has been shown in several animal models to preferentially direct the immune response to a cellular (e.g. T-cell), humoral (antibody) or mixed pathway and has been shown to involve upregulation of T-regulatory cells in some animal models.

It has the potential to be utilised in diseases for which antigenic epitope sequences have already been identified, such as: a number of infectious diseases, some cancers, autoimmune diseases (e.g., RA), allergic asthma and allergy, and select CNS diseases (e.g., Alzheimer's).

CEL-SCI believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study CEL-SCI treats patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with Multikine first, BEFORE they receive surgery, radiation and/or chemotherapy.

This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for the neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
CEL-SCI's Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer.

Per the study's protocol, newly diagnosed patients with advanced primary squamous cell carcinoma are treated with the Multikine treatment regimen for 3 weeks prior to the Standard of Care which involves surgery, chemotherapy and/or radiation. Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby better able to mount an attack on the tumor.

The aim of treatment with Multikine is to boost the body's immune system prior to SOC.

The company's LEAPS technology is currently being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by grants from the National Institutes of Health. The company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.